Ocrelizumab

[alanpgh]

How does Ocre q come out yet? I really want to know because I may have to go Of Tyabri soon.,I will need an alternative soon.

Depending on where you live, you might be able to get on the Expanded Access program for this drug.

just google ocrelizumab expanded access.

let us know how this works out and if you have any other questions.

good luck!

[palmtree]

How does Ocre q come out yet? I really want to know because I may have to go Of Tyabri soon.,I will need an alternative soon.

[Marco]

Drug company internal screw ups cost investors millions, but grossly fails MS patients with PPMS.

Patients have been waiting for the release of a new medication expected to revolutionize the medication marketplace for MS patients. The trial numbers for have been stellar that could benefit 75 to 80% of MS patients, but for over 10% of patients this will be the first medication for their condition.

Primary progressive MS patients have always had a tough row having an odd diagnosing, often quicker progressive disease course, but zero treatments. In comparison, regular MS patients having medications for nearly 25 years and about a dozen choices today.

The drug, Ocrelizumab, has been looming large on the horizon. The FDA agreed to hasten every approval necessary for the drug. The trials were great, drug demand high, neurologists ready to prescribe... so what happened?

The drug's approval was delayed because the drug company wasn't prepared to properly manufacture the medication. There's simply no excuse for this type of foolishness.

It's difficult to trust a company with your health that doesn’t have their act together. Not to mention the medication will most likely start north of $75k/annually (many estimates are closer to $150k/annually).

Roche will lose millions over the delay, but more importantly they failed tens of thousands of MS patients desperately waiting for the first medication for PPMS.

I wish patients could punish drug companies for being idiots, but we don't have that ability. We're simply left with a chronic, progressive disease eating away our brains for another 3 months because a drug company doesn’t have their act together.

[alanpgh]

Update on Ocrelizumab (brand name: OCREVUS)

This post is based on information MSWorld received today from Genentech:
(Some of you might already know this, but showing here in case this is new to you.)

PPMS patients who would like access to OCREVUS (the brand name for Ocrelizumab) can call the Genentech Trial Information Support Line at (888) 662-6728, and inquire about the Expanded Access Program (EAP). The EAP currently has 36 open sites across the US.
Details regarding the EAP can be found HERE.


This is some additional information from Genentech for RRMS patients:
For RMS (RRMS) patients, there are two open and recruiting Phase 3B clinical trials.
See links below for details:
OBOE:
https://clinicaltrials.gov/ct2/show/NCT02688985
CHORDS:
https://clinicaltrials.gov/ct2/show/NCT02637856


Also, this excerpt from the Genentech Press Release says:
“The extension is the result of the submission of additional data by Genentech regarding the commercial manufacturing process of OCREVUS, which required additional time for FDA review. The extension is not related to the efficacy or safety of OCREVUS.”

Hope this helps. Good Luck in finding the right treatment for your MS.

All The Best,
Alan

Information published online by MSWorld volunteers is not intended to be used toward the diagnosis or treatment of any medical condition.
For specific information and advice, consult your personal physician.

[pballer76]

March 28, 2017.

Oops I missed it

Thanks

[Marco]

http://www.businesswire.com/news/hom...A2-Ocrelizumab

The FDA just extended the review of Ocrelizumab.
The article doesn't give an anticipated date.

I hope the link works.

March 28, 2017.

[REG53]

That's disappointing.

[pballer76]

FDA Extends Review of Application for OCREVUS™ (Ocrelizumab)

http://www.businesswire.com/news/hom...A2-Ocrelizumab

The FDA just extended the review of Ocrelizumab.
The article doesn't give an anticipated date.

I hope the link works.

[pballer76]

Ocrelizumab

My MS specialist says ocrelizumab will be available in July 2017.

[lindaincolorado]

I am excited for ALL of you! I'm still a Tysabri gal every 56 days you know, if it ain't broke don't fix it
My best wishes

[alanpgh]

Others might qualify for this Expanded Access Trial.

And, hopefully, Ocrelizumab (Ocrevus) will be approved by the FDA in the near future.

Then, you'll be able to have your Neuro prescribe this if you and your healthcare team think it's the right treatment for you.

The good news is that this will likely be an additional treatment choice in the near future.

All The Best,
Alan

[kmallory1]

Well, I don't qualify since I'm over 55. Nobody wants to do clinical trials for us old people, lol.

If I'm reading it right, having been on Tysabri for over 12 months a few years ago is a disqualifier too.

[alanpgh]

Expanded Access Program for Ocrelizumab

Genentech has an Expanded Access Program for people diagnosed with PPMS.

See the link below:
http://www.nationalmssociety.org/Abo...Primary-Progre

The link above indicates, "Investigators Enrolling People with Primary Progressive MS for 'Expanded Access' to Ocrelizumab Before it Becomes Commercially Available in the U.S."

Here's the information about this trial, from the link above: (Ref. Study ID# ML29972)
Clinical Trial Information Support Line
Information about Genentech sponsored trials
(888) 662-6728
6 a.m. - 3 p.m. PST M-F
Reference Study ID Number: ML29972
global.rochegenentechtrials@roche.com

If you are interested, you might want to call.

Please let us know if they are still enrolling patients in this trial.

Best Wishes!

Alan

[palmtree]

I wonder if Genentech is going to help patients who do not have insurance or whose insurance doesn't cover it all. Biogen had so many programs.

One good thing: Ocrevus is not every month so I think it will be less expensive overall. I'm very curious about it, especially how people who switch from Tysabri to Ocre for RR and SP.

For PPMS, I'm so glad there is some hope.

[REG53]

Hi kmallory1, I am also waiting for it to be approved. My Neuro also said end of 2016, I hope it happens. When I was on tysabri which is an infusion, my medical ins covered it, not my medicare part D.